Clinical Benefits in Optimized Remote HF Patient Management

The outcome measure of the study is a combined endpoint of:

• Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
• Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management

Inclusion criteria

• Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
• 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months
• Left Bundle Branch Block (LBBB)
• Patients must be able to provide written informed consent
• Patients are mentally capable to participate in the Investigation (based on physician's discretion)

Exclusion criteria

• Patients already implanted with CRT or CRT-D device to be replaced
• Patients in long-standing persistent or permanent AT/AF
• Patients in dialysis treatment at the time of enrollment
• Patients in parenteral inotropic therapy at the time of enrollment
• Patients with epicardial Left Ventricular (LV) lead
• Patients with mechanical valvular prosthesis
• Patients with life expectancy < 12 months
• Patients actively considered for cardiac transplant
• Patients < 18 years old
• Pregnant women